Kornimate/medical-research-clean huggingface dataset:
study to evaluate drug-drug interaction between idx719 and simeprevir in healthy participants (mk-1894-004)

Conditions: Chronic Hepatitis C Infection

Summary: the purpose of this 3-part study is to evaluate the potential impact of simeprevir and food on pharmacokinetics (pk) of idx719 in healthy participants. part 1 will evaluate potential pk interactions between idx719 and simeprevir. part 2 will evaluate the effect of food on the pk of idx719 in combination with simeprevir. part 3 will evaluate the impact of high- versus low-fat meals on the pk of idx719.


Eligibility criteria:
inclusion criteria: * has no clinically significant abnormalities on medical history, physical examination, or 12-lead electrocardiogram (ecg) * agrees to use a double method of birth control (one of which must be a barrier) from screening through at least 90 days after the last dose of study drug * agrees to avoid nicotine-containing products from 3 months prior to screening and for the duration of the study exclusion criteria: * is positive for hepatitis b surface antigen (hbsag), anti-hepatitis c virus (hcv) antibodies, or anti-human immunodeficiency virus (hiv) antibodies * is pregnant or breastfeeding * has previously received either idx719 or simeprevir * has participated in another clinical drug study within 30 days of screening

Keywords: hcv hepatitis c virus hepatitis c antiviral drugs liver
impact of e-cigarette use on the body

Conditions: Cigarette Smoking-Related Carcinoma

Summary: this study examines how electronic (e)-cigarette use impacts the body, by studying both users and non-users of e-cigarettes. early evidence indicates that e-cig users experience adverse health effects. results of this study may help policy-makers develop standards for different types of tobacco.

primary objective: examine the short-term impacts of vaping on pulmonary and respiratory outcomes. outline: current e-cigarette users will vape their own e-cigarette device ad libitum for 30 minutes; non-users will watch a neutral video for 30 minutes. before and after the 30 minute vaping \[video\] session, participants will undergo the following assessments: computer-based spirometry testing, nitric oxide breath testing, airwave oscillometry, and an assessment of endothelial function. participants will also undergo collection of blood.

Eligibility criteria:
inclusion criteria: * 75 e-cig users and 75 never-users * no self-reported diagnosis of lung disease (e.g., coronavirus disease-2019 \[covid-19\], pneumonia, cystic fibrosis) * no history of cardiac event or distress * not currently breastfeeding, pregnant, or planning to become pregnant (e-cig users only; will be confirmed via pregnancy test)
personalized radiation therapy for gbm

Conditions: Glioblastoma

Summary: the study is a pilot study to estimate the efficacy of personalized dose-escalation radiation therapy in patients with glioblastoma, as measured by estimating the median of progression-free survival. toxicity, patterns of recurrence, and overall median survival will be measured as secondary endpoints. adverse events will be monitored.


Eligibility criteria:
inclusion criteria: * patients with biopsy-proven who grade iv glioblastoma, after gross-total or near-total resection, who are undergoing definitive chemoradiation as part of their treatment regimen * age 18 or older * ability to give signed informed consent * karnofsky performance status (kps) at least 70 exclusion criteria: * placement of gliadel wafers * participation in another investigational trial * active treatment of another malignancy
anterior ultrasound-guided cervical plexus block for carotid endarterectomy

Conditions: Carotid Atherosclerosis; Regional Anesthesia Morbidity

Summary: the aim of this study is to describe technique, efficiency, safety and satisfaction of ultrasound guided intermediate cervical plexus block for carotid endarterectomy. the investigators present a simple approach for carotid regional anaesthesia by an anterior way that has not been published yet.

* description of the anaesthetic procedure (duration, volume of anaesthetic local, efficiency) * realization of the surgery (pain, injection of anaesthetic local...) * post operative evaluation (pain, satisfaction...)

Eligibility criteria:
inclusion criteria: * adult * carotid endarterectomy performed under regional anaesthesia exclusion criteria: * age \< 18 years * contralateral phrenic palsy

Keywords: carotid endarterectomy regional anaesthesia ultrasound guided block
circulating tumor cells in patients with metastatic colorectal cancer

Conditions: Colorectal Cancer; Neoplasm Metastasis

Summary: this study enrolled patients with measurable metastatic colorectal cancer. blood was drawn prior to the patient receiving a new therapy for his/her cancer and subsequently at 7-14 days, 3-4 weeks, and when an imaging study was done (\~every 6 to 12 weeks). the blood was tested to find circulating tumor cells (ctcs) and to count them. the ctc levels were compared to the imaging study results to see if the ctc number and the imaging result (progression/no progression) were in agreement. maximum active study participation was 12 months with up to 8 blood draws being taken. all patients are currently being followed for up to 24 months from their off study date for survival. the ctc result will also be used to see if there is a difference in survival and progression-free survival for those patients with and without a certain number of ctcs.


Eligibility criteria:
inclusion criteria: * measurable metastatic carcinoma of the colon or rectum. * 1st or 2nd line chemotherapy (3rd line acceptable with epidermal growth factor receptor \[egfr\] targeted therapy) * chest/abdomen/pelvis scans every 6-12 weeks * ecog 0-2 * hemoglobin (hgb) \> or = 8g/dl within 7 days prior to enrollment * age \> or = to 18 years of age exclusion criteria: * cumulative weekly blood draws exceeding 150ml/week * brain metastasis * prior history of other carcinoma within the last 5 years, except ductal carcinoma in situ (dcis), non-invasive cervical cancer or non-melanoma skin cancer * surgery within 14 days of the initial blood draw, excluding surgical placement of a central venous device

Keywords: metastatic colorectal cancer
a study to investigate the effect of lepodisiran on the reduction of major adverse cardiovascular events in adults with elevated lipoprotein(a) - acclaim-lp(a)

Conditions: Atherosclerotic Cardiovascular Disease (ASCVD); Elevated Lp(a)

Summary: the purpose of this study is to evaluate the efficacy of lepodisiran in reducing cardiovascular risk in participants with high lipoprotein(a) who have cardiovascular disease or are at risk of a heart attack or stroke. the study drug will be administered subcutaneously (sc) (under the skin). approximately 1700 additional participants will be enrolled in an addendum to explore lp(a) lowering with an alternative dosing schema.


Eligibility criteria:
inclusion criteria: * have lipoprotein(a) \[lp(a)\] ≥175 nanomoles per liter (nmol/l). * meet criteria of either 2a or 2b: 2a: individuals 18 years of age or older with established atherosclerotic cardiovascular disease (ascvd) with an event or revascularization. 2b: individuals 55 years of age or older who are at risk for a first cardiovascular (cv) event and either: documented coronary artery disease (cad), carotid stenosis, or peripheral artery disease (pad) without history of event or revascularization; known familial hypercholesteremia; or a combination of high-risk factors. exclusion criteria: * have had a major cardiovascular event or surgery, such as myocardial infarction (mi), stroke or coronary or peripheral revascularization, \< 60 days before screening * have uncontrolled hypertension * have new york heart association class iv heart failure. * have lipoprotein apheresis within 90 days of screening, or planned lipoprotein apheresis during the study. * have severe renal failure, defined as * estimated glomerular rate (egfr) \<15 milliliters per minute per 1.73 meters squared (ml/min/1.73m2) at screening visit 1, or ongoing dialysis. * have a diagnosis of active nephrotic syndrome, or urine albumin-creatinine ratio (uacr) of ≥5000 mg/g at screening visit 1. * have acute or chronic hepatitis, known cirrhosis, signs and symptoms of any other liver disease other than metabolic-associated steatotic liver disease, or exclusionary laboratory results as determined by the central laboratory during screening.

Keywords: ascvd ly3819469 lepodisiran
esomeprazole versus pantoprazole to prevent peptic ulcer rebleeding

Conditions: Peptic Ulcer

Summary: the aim of this study is to compare the clinical effectiveness of intravenous esomeprazole and pantoprazole in preventing recurrent bleeding in the patients with high-risk bleeding peptic ulcers after successful standard endoscopic hemostasis.

endoscopic hemostasis and proton pump inhibitor (ppi) constitute the cornerstone in the management of peptic ulcer bleeding (pub), which remains a prevalent disorder associated with substantial morbidity and mortality. clinical effectiveness of ppi in the management of patients with pub has been established by compelling evidence derived from a number of randomized trials. however, whether different ppis are equally effective has not been investigated. esomeprazole, the s-isomer of omeprazole, may achieve faster, more profound and steady acid suppression than other ppis, but it remains undetermined whether the superiority of pharmacologic efficacy may be translated into advantages in clinical outcomes.

Eligibility criteria:
inclusion criteria: * aged more than 18 years * undergo emergent endoscopy within 24 hours of presentation * have peptic ulcers in the gastroesophageal junction, stomach, or duodenum * high-risk stigmata of peptic ulcers: forrest classification ia\~iib * endoscopic hemostasis by thermocoagulation or clip placement exclusion criteria: * pregnant or lactating * written informed consent not obtained * initial endoscopic hemostasis fail * bleeding tendency (platelet count \< 50×109/l, prolonged prothrombin time for more than 3 seconds, or were taking anticoagulants) * ppi use within 14 days of enrollment * comorbid with severe hepatic or renal insufficiency (serum total bilirubin more than 5 mg/dl, serum creatinine more than 5 mg/dl, or under dialysis) * bleeding gastric cancers

Keywords: peptic ulcer bleeding proton pump inhibitor esomeprazole pantoprazole recurrent bleeding bleeding
high on treatment platelet reactivity following peripheral endovascular procedures

Conditions: Influence of PRU Values on Primary Outcome

Summary: antiplatelet therapy with clopidogrel is recommended following peripheral endovascular procedures. the clinical significance of an inadequate response to clopidogrel following percutaneous coronary interventions has been recently recognized.this study was designed to investigate platelet responsiveness to clopidogrel following endovascular therapy of peripheral arterial disease using the verifynow p2y12 point-of-care testing and to determine the optimal p2y12 reactive unites (pru) cut-off value of platelet inhibition influencing outcomes of infrainguinal angioplasty or stenting in patients receiving clopidogrel antiplatelet therapy.


Eligibility criteria:
inclusion criteria: * patients suffering from rutherford 3-6 stage of peripheral arterial disease scheduled to undergo femoropopliteal or and infrapopliteal angioplasty or stenting. * patients receiving clopidogrel per os 75 mg daily at least 1 month prior and 1 year after the procedure. exclusion criteria: * acute limb ischemia * coagulation disorders * known allergy to clopidogrel * failure to comply with the antiplatelet treatment protocol * aortoiliac disease

Keywords: clopidogrel platelet inhibition antiplatelet therapy peripheral arterial disease endovascular treatment angioplasty stenting
evaluation of the effect on glucose control of ac2993 in patients with type 2 diabetes mellitus treated with metformin

Conditions: Diabetes Mellitus, Type 2

Summary: this is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of ac2993 as compared to placebo in patients with type 2 diabetes. patients will be randomized into one of two ac2993 treatment arms or to placebo treatment and will continue with their required existing diabetes medication (metformin) throughout the study.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes mellitus * treated with metformin within a defined dose range for at least 3 months prior to screening * bmi= 27-45 kg/m2 * hba1c value between 7.5% and 11% exclusion criteria: * treated with oral anti-diabetic medications other than metformin within 3 months of screening * patients treated previously with ac2993 * patients presently treated with insulin
transfected dendritic cell based therapy for patients with breast cancer or malignant melanoma

Conditions: Breast Cancer; Malignant Melanoma

Summary: the primary aim of this study is to evaluate the toxicity of the vaccine and the combination of the vaccine and cyclophosphamide, and to evaluate the immune response induced by the vaccine. the secondary aim is to investigate the clinical tumour response and duration of tumour and immune response.

phase i trial. single center study; patients will be referred to the study center from other institutions in denmark. 14 patients will be included in this phase i trial dc vaccination regime consists of primary 6 biweekly intradermal injections with transfected dendritic cells, followed by monthly injections until progression; cyclophosphamide is used as vaccine adjuvant. defined procedures are employed for generation of autologous dendritic cells for clinical application in a classified laboratory. unmobilized leukapheresis will be used for isolation of large-scale mononuclear cells, and dendritic cells will be generated from monocytes by cytokine stimulation and transfected with mrna encoding for htert, survivin and p53 if the tumour express p53. frozen preparations of dendritic cells will be prepared using automated cryopreservation. each patient will receive a minimum of 1x106 dendritic cells per treatment supplemented with cyclophosphamide 50 mg twice a day every second week. toxicity including autoimmunity will be evaluated using the common toxicity criteria (ctc).

Eligibility criteria:
inclusion criteria: 1. histological verified metastatic breast cancer or malignant melanoma, in progression 2. ≥ 18 years 3. the patient must be habil 4. performance status ≤ 1 on zubrod-ecog-who-scale 5. leukocytes and platelets must be ≥normal. hg ≥ 6.0 6. creatinin must be normal 7. liverparametre \<2.5 x normal. bilirubin \<30 8. expected survival \> 3 months 9. informed consent 11. at least one measurable lesion according to recist criteria. exclusion criteria: 1. indication for chemotherapy 2. other malignancies 3. brain metastases 4. severe medical condition 5. acute/chronic infection with ex. hiv, hepatitis, tuberculose 6. severe allergy 7. autoimmune disease 8. other treatment with immune suppressing agents, other anticancer agents or experimental drugs 9. uncontrolled hypercalcemia.

Keywords: dendritic cell cancervaccine breast cancer malignant melanoma cyclophosphamide
extracorporal shock wave treatment to improve nerve regeneration

Conditions: Peripheral Nerve Injury

Summary: this study evaluates the impact of extracorporeal shock wave treatment after microsurgical coaptation of finger nerves. participants will be randomized into two treatment groups with different settings and a sham group. the participants will thereafter followed-up in a prospective, double-blind study design.

extracorporeal shock wave treatment is ce certified in austria, europe and licensed for indications like achillodynia, epicondylitis, or tendinitis calcanea. the orthogold 100 device by mts medical ug will be used for this study. defocused low-energy extracorporeal shock wave therapy (eswt) has gained acceptance as a therapeutic tool in different medical settings. it has been shown, that shock waves stimulate of the metabolic activity of different cell type, including osteoblasts, tenocytes, endothelial cells and chondrocytes. furthermore, it has proved effective in clinical applications relating to bone and wound healing and myocardial ischaemia. until now, no studies have been performed regarding the effects of eswt on regeneration of peripheral nerve injuries in humans.

Eligibility criteria:
inclusion criteria: * complete lossless transection of one or more digital nerves distal to the branching out of the commune median or ulnar nerves * direct, tension-free coaptation of the nerve stumps exclusion criteria: * segment loss of the nerve * tension after direct coaptation * diabetic neuropathy or other peripheral neuropathies * other disease with reduced sensibility of the fingers * injuries in the course of the nerve (plexus brachialis, median or ulnar nerve) * chronic inflammatory disease * rheumatoid arthritis * pregnancy * patients not able to give written consent * patients with an implantable cardiac defibrillator or pacemaker * patients which are sensitive to electromagnetic radiance

Keywords: extracorporeal shock wave microsurgical nerve coaptation nerve regeneration
fruits and vegetables incentives study

Conditions: Obesity; Fruit and Vegetable Intake; Healthy Diet

Summary: the goal of this study is to evaluate the effectiveness of financial incentives delivered in real-time at point of purchase, on low-income consumers' purchase of fruits and vegetables, fruits and vegetables consumption, diet quality, and weight/bmi. the study will test real-time incentives compared to a no-incentive control condition.

to address diet quality disparities in low-income families, policy makers and health experts recommend strategies such as financial incentives to promote consumption of fruits and vegetables. real-time incentives for purchasing fruits and vegetables are promising strategies to improve families' diets and health. the aims of the study are: 1. to test the effects of financial incentives, delivered in real-time at the point of purchase, on low-income consumer purchases of fruits and vegetables 2. to evaluate the impact of real-time financial incentives compared to a control condition on fv consumption among adults and their children ,shopping habits, home food environments, diet quality, and weight/bmi 3. to adapt mobile platform technology to provide regular feedback to participants to motivate use of the incentive program to increase purchases and consumption of fruits and vegetables 4. to evaluate participant satisfaction with real-time healthy food choice incentives technology in both snap participants and income-eligible non-snap participants 5. to assess the acceptability and ease of use of real-time healthy food choice incentives technology among retails supermarket managers and staff in low-income neighborhoods.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * speak english * do most of their food shopping at a participating supermarket * receive or are eligible to receive snap benefits * have a child in the household between the ages of 2-17 * have a working smartphone * be the main household shopper exclusion criteria: * participants will be excluded if the primary shopper and/or any children in the family have major medical or dental conditions that would prevent them from eating fruits and vegetables, or if they have a serious neurological disorder, dementia, or psychiatric condition that interferes with understanding study procedures

Keywords: nutrition health disparities food purchases
phase ii trial of double dose of icotinib in treating brain metastases from non-small cell lung cancer

Conditions: Brain Metastases; Non-small Cell Lung Cancer

Summary: brain metastases, a common complication,occur in 25-40% of patients with non-small cell lung cancer (nsclc). whole-brain radiation therapy(wbrt) and stereotactic radiosurgery (srs) are important approaches to the treatment of brain metastases from nsclc. known to us, epidermal growth factor receptor tyrosine kinase inhibitors (egfr-tkis) can pass through the blood-brain barrier and show promising antitumor activity against brain metastases from nsclc, especially for egfr mutation patients. however, due to the lower concentration of tyrosine kinase inhibitors (tkis) in the cerebrospinal fluid and its inevitable emergence of drug resistance, brain metastases will be refractory or resistant to standard-dose egfr inhibitors. icotinib is one agent of egfr-tkis. the previous studies have shown that the icotinib conventional dose (125mg, tid) is far from reached its maximum tolerable dose. it is a challenge whether the further dose escalation of icotinib will enhance its concentration in cerebrospinal fluid and thereby improve its therapeutic effect. here the investigators examine the therapeutic effect and side-effect of double dose of icitinib in treating patients with brain metastases from nsclc who have suffered from the failure of conventional dose treatment.


Eligibility criteria:
inclusion criteria: * histological or cytologic diagnosis of nsclc * patients with disease progression after local treatment(wbrt and/or srs) combined with icotinib treatment. * patients with egfr mutation or the lesions that remains stable for more than 3 months after local treatment(wbrt and/or srs) combined with icotinib treatment. * ecog performance status 0-2 * doctors consider the patients will not benefit from local treatment(wbrt and/or srs) * expected survival of greater than 3 months * age: 18-75 years * the patients with key organs maintenance of basic function: hemoglobin ≥ 9g/dl, white blood cell ≥ 3×109/l, neutrophil count ≥ 1.5×109/l, platelets ≥ 80×109/l, total bilirubin \< 1.5 times of the upper normal values, alanine transaminase (alt) and aspartate transaminase (ast) \< 2.5 of the upper normal values, the serum creatinine \< 1.5 times of the upper normal values * signed informed consent document on file. exclusion criteria: * brain metastasis without local treatment before * patients without the treatment of icotinib before or the therapeutic time less than 3 months * more than 3 extracranial organs have metastatic lesions * the patient with other type malignant tumors before * the patient with fertility capacity, but without contraceptive application